Trasylol
Drug used to prevent bleeding during heart surgery linked to serious side effects – including kidney failure, stroke, heart attack, and death
Keywords: Trasylol | Attorney | Santa Rosa | Lawyer | Lawsuit | Kidney / Renal Failure | Heart Attack / Failure | Stroke | Death
In November 2007, Trasylol was removed from the market at the request of the U.S. Food and Drug Administration (FDA). Trasylol had been used in one third of all open heart surgeries in the United States since 1993. The purpose of the drug was to reduce blood loss during cardiac surgery. In 2007, however, researchers conducted a randomized study and discovered that Trasylol put patients at a greater risk of death than two less expensive drugs available for the same purpose. Evidence shows that Bayer Pharmaceuticals Corp., the manufacturer of the drug, continued to market Trasylol despite awareness of the life-threatening risks it posed to patients.
Trasylol (aprotinin) is an antifibrinolytic drug injected during heart bypass surgery to help reduce bleeding and the need for blood transfusions. Researchers at the Ottawa Health Institute stopped a clinical study of Trasylol in October 2007 because the drug appeared to increase the risk of death when compared to two other anifibrinolytic drugs. The data showed that Trasylol increased the chance of death by 54 percent when compared to the two much cheaper alternatives, Amicar and Cyklokapron. The FDA requested that Bayer suspend all marketing of Trasylol based on these findings.
Back in September 2006, Dr. Dennis Mangano presented a study to the FDA which showed that Trasylol increased the risk of kidney failure requiring dialysis after heart surgery. Bayer executives, however, stood before the panel of FDA safety experts and Dr. Mangano and defended the safety of Trasylol – ultimately convincing the FDA that Trasylol should stay on the market. At this time, Bayer had already conducted its own study of Trasylol that revealed the drug's dangerous propensity, including the risk of kidney damage, heart failure, stroke, and death. Bayer did not disclose its findings to the FDA.
After convincing the FDA at this September 2006 meeting that Trasylol should remain on the market, Bayer realized $135 million in sales of Trasylol before it was eventually pulled from the market in November 2007.
From the time he published his study in January 2006 until the drug was pulled from the market, Dr. Mangano estimates that 22,000 lives were lost to Trasylol – approximately 1,000 lives per month. In February 2008, two additional studies were published in the New England Journal of Medicine confirming the dangers of Trasylol.
Additional Information on Trasylol
60 Minutes Report (report follows brief advertisement)
Manufacturer Removes Remaining Stocks of Trasylol
FDA Patient Safety News
FDA Requests Marketing Suspension of Trasylol
Marketing Suspension of Trasylol
Canada NewsWire (press release), Canada - Mar 30, 2007
Trasylol News Articles
MSNBC
New York Times
Nightly News with Brian Williams - Feb 20, 2008 (MSNBC video)
FOX News - Feb 7, 2007
U.S. News & World Report
Washington Post
Lawsuit
If you or a loved one has suffered injury or death after taking Trasylol, you may have valuable legal rights. For a free and confidential consultation, please fill out the form to the right or contact attorney Tarik J. Naber at (707) 545-1660 or tnaber@gsoglaw.com.
